美国FDA指导原则 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments.docxVIP

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美国FDA指导原则 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments.docx

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Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments Document issued on : May 12, 2004 The draft of this document was issued on May 14, 2002 This document supersedes: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA issued May 14, 2002 Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants; Final, 04/21/1999 Information Necessary for Premarket Notification Submissions For Screw-Type Endosseous Implants, 12/09/1996 Guidance For the Arrangement and Content of a Premarket Approval (PMA) Application for An Endosseous Implant For Prosthetic Attachment, 5/16/89 (parts of) Calcium Phosphate(Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants, 2/21/97 For questions regarding this document, contact Andrew Steen at 301-796-6284 or by email at andrew.steen@ U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health Dental Device BranchDivision of Anesthesiology, Infection Control, General Hospital, and Dental DevicesOffice of Device Evaluation TABLE OF CONTENTS 1.? INTRODUCTION2.? BACKGROUND3.? THE CONTENT AND FORMAT OF AN ABBREVIATED 510(k) SUBMISSION4.? SCOPE5.? DEVICE DESCRIPTION6.? RISKS TO HEALTH7.? MATERIAL COMPOSITION8.? MECHANICAL PROPERTIES9.? IMPLANT TO ABUTMENT COMPATIBILITY10.? CORROSION TESTING11.? MODIFIED SURFACES INFORMATION12.? CLINICAL STUDIES13.? LABELINGAPPENDIX I? SUGGESTED FORMAT FOR TEST REPORTS Preface Public Comment Written comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-3